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Blood, tissue and cell therapies save countless lives each year – now, with even greater safety and quality

On 14 July, the Commission proposed a broad revision of the existing legislation to ensure the safety and quality of blood, tissues and cells, updating and strengthening the rules. Andrzej Rys, (Director SANTE B - Health systems, medical products and innovation) discusses the impact of these changes, which the proposal extends to other substances of human origin (SoHO) such as breast milk.

date:  20/07/2022

How does the legislation on blood, tissues and cells help EU citizens? 

This proposal will upgrade the EU framework that ensures that blood, tissues and cells used for medical treatment do not transmit disease and continually bring real benefits for patients.  

Just looking at blood alone, we currently have 15 million blood donors in the EU, so you can see the importance of having clear and strict rules in place to make sure that donations are safe, that they will work as intended in the patient and that donors that provide them are not put at risk. These treatments form a critical part of the healthcare system across all EU Member States, making emergency care, transplants and other surgeries possible, and saving countless lives each year. 

Some 25 million units of blood are transfused and some 940 000 cycles of IVF are performed yearly in the EU. The transplantation of bone stem cells, in bone marrow for example, cure cancer and other life-threatening conditions in tens of thousands of patients.  

SoHO treatments also improve people’s quality of life. For example, 14 500 corneal transplants improve the sight of EU patients each year, and hundreds of transplants of heart valves, particularly in children, help make it possible for those patients to enjoy a healthy and active life.  

Why is a revision of the existing legislation necessary? 

This new legislation will replace the rules for safety and quality set out in Directives 2002/98/EC, for blood and blood components and 2004/23/EC, for tissues and cells. The legislation improved safety and quality in this field across the EU for many years, but an evaluation carried out in 2019 identified certain gaps and shortcomings.  

In particular, new infectious disease risks had emerged in the meanwhile and technologies for processing blood, tissues and cells had developed rapidly. The rules have not kept pace with these changes.  

In addition, donors were not prioritised in terms of health protection and the legislation was applied inconsistently across the EU.  

More recently, the COVID-19 pandemic also highlighted concerns about having sufficient supply. It was apparent that the legislation needed to better address this issue.  

Challenges were also seen for those developing innovative ways of preparing blood, tissues and cells before clinical use and the systems for approving new methods of preparation were considered insufficient for such a rapidly evolving, innovative field. 

The revision put forward addresses these shortcomings to ensure that the framework is up-to-date, fit for purpose and future-proof.  

What will this mean in practical terms?  

Two Directives – one on blood and one on tissues and cells - have now been merged into a proposal for a single Regulation, directly applicable in Member States.  

The approach to technical rules is more flexible so that ongoing scientific and technological developments are addressed promptly. To this end, many technical provisions are removed from the legislation and replaced by general standards.  

Importantly, the proposal brings new measures to ensure the health and welfare of donors. They ensure that donors are healthy enough to donate, that any adverse outcomes are reported and that donor health is monitored if their donation involves any risk to them. 

In addition, the important topic of innovation is also tackled. A new advisory mechanism will help developers clarify whether a new way of processing or using blood, tissues and cells might require changing the regulatory status of the substance. The authorisation of new processes will be strengthened to ensure that safety is clearly demonstrated and that innovation brings real benefit for patients. 

Drawing on lessons learnt from the COVID-19 pandemic, the proposal also requires emergency plans to be in place at local and national level for substances that are critical for patient treatment. A new EU level IT platform will collect data on donation rates, treatments, imports and exports. Making the supply chain visible will help Member States take policy decisions when the supply is at risk of being insufficient and it will be easier for Member States to co-operate to solve problems caused by sudden supply interruptions.  

What are the next steps? 

Now that the Commission has adopted the proposal, it will proceed through the co-decision process in the Parliament and the Council of the European Union until a final text is agreed.  


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